Donald W. Fink, Jr. (2009). FDA Regulation of Stem Cell-Based Products. Science, 324:1662-1663.
CHAPTERS/BOOKS
KE Sung, J Arcidiacono, DW Fink, Jr, A Gray, J Lam, W Tang, I Wu, RK Puri. (2020). The regulatory process from concept to market. In R Lanza, R Langer, JP Vacanti, and A Atala (Eds.), Principles of Tissue Engineering (5th Edition), London, UK; Waltham, MA-USA; and San Diego, CA-USA: Elsevier-Academic Press, pp. 1553-1572.
MH Lee, KJ Whittlesey, JM Dang, M Colehour, J Arcidiacono, E Lazarus, DS Kaplan, DW Fink, CN Durfor, A Batra, S Hilbert, DL Grayeski, R McFarland, and C Witten (2013). Overview of the FDA Regulatory Review Process. In R Lanza and A Atala (Eds), Handbook of Stem Cells, Vol 1: Pluripotent Stem Cells (2nd Edition), London, UK; Waltham, MA-USA; and San Diego, CA-USA: Elsevier-Academic Press, pp. 1001-1019.
DW Fink, Jr., and Bauer, SR. (2009). Stem Cell-based Therapies: FDA Product and Preclinical Considerations. In The Essentials of Stem Cell Biology (2nd edition). Ed. R Lanza, J Gearhart, B Hogan, D Melton, R Pedersen, J Thomson, E Thomas and I Wilmut; Elsevier Academic Press: Burlington, MA, pp. 619-630.
Fink, D.W., Jr. (2004). Human Embryonic Stem Cells: Regulatory Considerations. In [Hand Book of] STEM CELLS: Volume 1- Embryonic Stem Cells. Ed. R Lanza, J Gearhart, B Hogan, D Melton, R Pedersen, J Thomson and M West; Elsevier Academic Press, Boston, MA, San Diego, CA, London, UK, pp. 775-786.